Protokol štúdie Sample Clauses

Protokol štúdie. A. The Site will conduct the study entitled “A Phase 3 Randomized, Double-blind, Placebo- controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)” (the “Study”) at Institution in strict accordance with the Protocol, incorporated herein by reference, as may be further amended pursuant to the terms of this Agreement (the “Protocol”). The Protocol sets forth the clinical research activities and responsibilities to be undertaken, pursued, and followed with all due diligence by the Site. The Protocol shall be considered final after it is signed by Sponsor and the Investigator and approved by the relevant Ethics Committee (“EC”) and regulatory agency (“RA”). Thereafter, the Protocol may be amended only by prior written consent of Sponsor and subsequent approval by the EC/RA. The Parties agree that in the event of a conflict between the terms of the Protocol and the terms of this Agreement, the terms of this Agreement shall govern, except in the case of matters relating directly to clinical procedures or patient safety, with respect to which the terms of the Protocol shall prevail. A. Pracovisko vykoná štúdiu s názvom Randomizované, dvojito zaslepené, placebom kontrolované klinické skúšanie fázy 3 prebiehajúce v paralelných skupinách, na sledovanie účinnosti a bezpečnosti skúšaného produktu SHP647 ako zahajovacej liečby pacientov so stredne ťažkou až ťažkou formou ulceróznej kolitídy (FIGARO UC 302) (ďalej len „štúdia“) v inštitúcii v prísnom súlade s protokolom, ktorý je tu zahrnutý formou odkazu a ktorý môže byť ďalej upravený v súlade s podmienkami tejto zmluvy (ďalej len „protokol“). Protokol stanovuje činnosti a zodpovednosti v rámci klinického výskumu, ktoré sa na pracovisku majú vykonávať, sledovať a dodržiavať so všetkou náležitou starostlivosťou. Protokol sa považuje za konečný po jeho podpísaní zadávateľom a skúšajúcim a schválení príslušnou etickou komisiou (EK) a regulačnou agentúrou (RA). Následne sa protokol môže meniť a dopĺňať len s predchádzajúcim písomným súhlasom zadávateľa a následným schválením etickou komisiou a regulačnou agentúrou. Zmluvné strany sa dohodli, že v prípade rozporu medzi podmienkami protokolu a podmienkami tejto zmluvy platia podmienky tejto zmluvy, s výnimkou prípadov, ktoré sa týkajú priamo klinických postupov alebo bezpečnosti pacientov, kedy majú prednosť podmienky protokolu. Notwithstanding the foregoing, the Parties acknow...
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Protokol štúdie. Protokol sa bude považovať za finálny vtedy, keď dôjde k jeho uskutočneniu zadávateľom a zodpovedným skúšajúcim a keď bude schválený príslušnou kompetentnou etickou komisiou alebo internou kontrolnou komisiou („etická komisia“) a podľa potreby Štátnym ústavom na kontrolu liečiv („ŠÚKL“).

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